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Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries

Primary Purpose

Delirium in Old Age

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAM score
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium in Old Age

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >60 years. American Society of Anesthesiologists physical status I, II. Patients undergoing hip fracture surgeries under spinal anaesthesia Exclusion Criteria: • History of neurological or psychiatric disease. Allergy to local anaesthetics. Infection in the injection area. Regular medication with tranquillizers and/or antidepressants. CAM scores II-VI. Delayed fracture surgeries more than 48 hours. Intraoperative blood loss of more than 1000 ml. Patient refusal.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    spinal anesthesia only

    spinal anesthesia with erector spinae block

    Arm Description

    The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl

    The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl, then erector spinae block will be given The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspira¬tion, 20 ml of 0.25% bupivacaine will be injected

    Outcomes

    Primary Outcome Measures

    post operative delirium
    occurrence and severity of cognitive dysfunction

    Secondary Outcome Measures

    complications from erector spinae block
    block failure, haematoma

    Full Information

    First Posted
    March 29, 2023
    Last Updated
    April 17, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05819723
    Brief Title
    Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
    Official Title
    Analgesia Produced by Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not!
    Detailed Description
    This randomized controlled trial will include 120 elderly patients American Society of Anesthesiologists physical status I-II, aged more than 60 years old and undergoing fracture hip surgeries. all patients will be examined for preoperative cognitive impairment using the short form of the Confusion Assessment Method Survey (CAM) and the long form will be used postoperatively. The CAM scores is an algorithm that consists of four features: (i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness.CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present. Patients with a delirium of CAM score>1 will be excluded from the study. also, patients will be asked to rate their baseline pain levels using the numeric rating scales (NRS) from "no pain" to "worst possible pain". patients will be randomly divided into two equal groups Group 1: spinal anaesthesia only. Group 2: spinal anaesthesia with erector spinae block. In both groups, basic monitoring in the form of non-invasive blood pressure (NIBP), pulse oxygen saturation (SPO2)and 5-lead electrocardiogram (ECG) will be attached in the operating room(OR) The spinal anaesthesia will be done in both groups under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl. At the end of the operation patients in group 2 will receive the block at the lateral position. The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspiration, 20 ml of 0.25% bupivacaine will be injected. patients will be monitored in the PACU for at least one hour by NIBP, SPO2, and ECG and any abnormality will be recorded and managed accordingly. The cognitive functions will be re-evaluated one hour after the recovery from the surgery in PACU using the CAM scores. and on the first and the second days postoperatively using CAM score for occurrence and severity of cognitive dysfunction if present. Then every symptom will be rated and listed in the CAM-S as absent (0, mild (1), or severe (2), where higher scores indicate more severe delirium and patients with POD will be followed up and managed properly by neurologists. Patients in the two groups will be compared regarding the incidence and severity of delirium on the first and second postoperative days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium in Old Age

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    spinal anesthesia only
    Arm Type
    Active Comparator
    Arm Description
    The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl
    Arm Title
    spinal anesthesia with erector spinae block
    Arm Type
    Active Comparator
    Arm Description
    The spinal anaesthesia will be done under a complete aseptic technique induced using 3ml bupivacaine 0.5% with 25μg fentanyl, then erector spinae block will be given The transverse process of the 4th lumbar vertebra will be identified 4-6 cm laterally to the midline. An echogenic needle will be inserted using the out-of-plane technique until it touches the transverse process. Following negative aspira¬tion, 20 ml of 0.25% bupivacaine will be injected
    Intervention Type
    Other
    Intervention Name(s)
    CAM score
    Intervention Description
    The CAM scores assess the presence of delirium rapidly and accurately and also differentiates delirium from other cognitive impairment with a sensitivity of 94-100% and specificity of 90-95%. It is an algorithm that consists of four features: (i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness. CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present.
    Primary Outcome Measure Information:
    Title
    post operative delirium
    Description
    occurrence and severity of cognitive dysfunction
    Time Frame
    first days postoperative
    Secondary Outcome Measure Information:
    Title
    complications from erector spinae block
    Description
    block failure, haematoma
    Time Frame
    on the first and the second days postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >60 years. American Society of Anesthesiologists physical status I, II. Patients undergoing hip fracture surgeries under spinal anaesthesia Exclusion Criteria: • History of neurological or psychiatric disease. Allergy to local anaesthetics. Infection in the injection area. Regular medication with tranquillizers and/or antidepressants. CAM scores II-VI. Delayed fracture surgeries more than 48 hours. Intraoperative blood loss of more than 1000 ml. Patient refusal.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rania M Hussien, associate professor
    Phone
    026213948
    Email
    drrania_maamon@med.asu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries

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